Farmacopeade los EstadosUnidos Mexicanos (FEUM by its ... · • Cover the essential medicines list used in Mexico. • Include the generic list • biotechnological products GoalsforMxPh

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UBALDO JUAREZ SEVILLA. Deputy DirectorRAFAEL HERNANDEZ MEDINA. Technical and Publications Manager

Address:Río Rhin 57, Col. Cuauhtémoc.CP 06500, Ciudad de México. México.

Tel.: +52 55 5207-6887http://[email protected]

MEET THE WORLD PHARMACOPOEIAS SYMPOSIUM

20 February, 2020

Strasburg, France

Name of pharmacopoeia

Farmacopea de los Estados Unidos Mexicanos

(FEUM by its acronym in Spanish)

Mexican Pharmacopoeia

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1846

Firstedition

Secondedition

Pharmaceutical Academy of the Capital of the Republic

1874 1884

Thirdedition

Fourthedition

Fifthedition

Sixthedition

1896 1904 1925 1952

MexicanPharmaceutical

Society

Mexican Pharmacopoeia

New Mexican Pharmacopoeia

1930 1952 1962 1974

Oficial

Firstedition

Secondedition

Thirdedition

Fourthedition

National Pharmacopoeia of the United Mexican States

Mexican Pharmacopoeia is referred in national legislation:

• General Health Act.: It states that drugs and other health products are regulated by the Mexican Pharmacopoeia; Articles 195, 200, 224, 258 and 370

• Regulation of health products, articles on the 2nd,

7th, 8th, 13th,17th, 21st , 75th and 167th

• Technical Regulation: Mexican Official Standard NOM-001-SSA1-2010, that establishes the procedure by which the review, update and edit of the Pharmacopoeia of the United Mexican States. The Mexican pharmacopoeia is also referred to other Mexican standards.

Pharmacopoeia referred in national legislations

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National legislation includes different reference

• General Health Act. in Mexico states that:

The quality specifications of medicines, excipients, active pharmaceutical ingredient and medicines are those indicated in the current edition of the Mexican Pharmacopoeia. When it does not contain the information, the pharmacopoeias of other countries may be used. (Or other internationally recognized by scientific literature)

In order to get the health registration for medicines, it requires that specifications for identity and purity are consistent as indicated in FEUM.

Regulation of Health Supplies

Art. 167, 173, 174 y 178 of RIS. DOF 04/feb/1998

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Scope

• The Mexican Pharmacopoeia has a wide scope, since it has publications for: allopathic, homeopathic, herbal medicines, medical devices and for storage and distribution activities for health supplies.

FEUM 12ª ED.General methods of analysis 139Excipients 188API 559Pharmaceutical preparations 735Gases for medicinal use 11Biological products 41Biological product methods 64 Biotechnological products 16Blood-derived medicines 29Disolution profile 16Crytical systems 24Radiopharmaceuticals Is excludedBasic tests 73Bioequivalence Guides 13

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99

OnlineNew publications and advances

• 119 Official monographs.• 16 Extra monographs - Pharmacopoeia.• 46 General Methods of Analysis.

Pharmacopoeia Herbal of the United Mexican States 2nd ed, 2013.

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• 468 Monographs of excipients for homeopathic medicines.

• 105 Monographs of tinctures and homeopathic trituration.

• 1 chapter of homeopathic pharmacy.

Homeopathic Pharmacopoeia of the United Mexican States 3th ed, 2015.

• General information• 330 Solutions and reagents• 60 General Methods of Analysis• 171 Medical Device Monographs• 53 Radiopharmaceutical monographs• 10 Appendices

Supplement for medical devices 4th ed., 2017.

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• Currently, the Mexican Pharmacopoeia it's working in a program for the establishment of pharmaceutical reference substances.

• Our main goal is to have the 100 substances most used in Mexico.

REFERENCE SUBSTANCES FEUM

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Who is responsible for FEUM?

Endorse and formalize

It is the advisory body

Compliance monitoring

Usuarios

Feedback

Industry 24%

Universities37%

Government39%

Permanent Commision – Technical & Scientific Assessor

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Stakeholder interaction

• Permanent representation of professionals in the various committees of the CPFEUM.

• Everyone can comment on what has already been published.

• Everyone can comment during the periods of consultation of FEUM users.

• Everyone can propose monographs for inclusion and review (technical justification)

1. The Mexican Pharmacopoeia is recognized as an official reference in some countries of the Americas such as: El Salvador, Guatemala, Costa Rica, Chile, Colombia, Peru, among others. It is in the interest of FEUM to work together with PAHO / WHO so that the Mexican Pharmacopoeia is increasingly useful in Spanish-speaking countries and promote the development of the Americas.

2. Establish collaboration agreements with PAHO / WHO for the development of reference substances that are necessary in Latin America (e.g. reference substances for neglected diseases such as Chagas).

3. Strengthen the development of standards for biological and biotechnology of interest to Mexico and the region.

EXPECTATIONS

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Increase the monographs considering the followingpriorities:

• Cover the essential medicines list used in Mexico.• Include the generic list • biotechnological products

Goals for MxPh

STRATEGY FOR THE FUTURE

• Identify the needs of the health authority and users, to maintain

current pharmacopoeia.

• Continue promoting the approach of users to participate in the

development of the monographs.

• Establish a closer communication with our colleagues in other

parts of the world.

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Expectations

• Exchange of information to respond in time to the needs.

• Closer collaboration with the world's leading pharmacopoeias.

• Be the bridge between Spanish-speaking countries and the

world's leading pharmacopoeias.

• Access to consultations to the main pharmacopoeias.

.

UPDATE OF PUBLICATIONS OF THE MEXICAN PHARMACOPOEIA

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¡GRACIAS!www.farmacopea.org.mx